Clinical Trials Register

Summary
EudraCT Number:	2015-004550-18
Sponsor's Protocol Code Number:	TV48125-CNS-30051
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-06-09
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2015-004550-18

A.3

Full title of the trial

A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of TEV 48125 for the Preventive Treatment of Migraine

Estudio multicéntrico, aleatorizado, de doble enmascaramiento y con grupos paralelos que evalúa la seguridad, tolerabilidad y eficacia a largo plazo de la administración subcutánea de TEV-48125 para el tratamiento preventivo de la migraña

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A clinical trial of TEV-48125 to evaluate long term safety, tolerability and efficacy for the Preventive Treatment of Migraine

Un ensayo clínico con TEV-48125 para evaluar la seguridad a largo plazo, la tolerabilidad y la eficacia frente al tratamiento preventivo de la migraña.

A.4.1

Sponsor's protocol code number

TV48125-CNS-30051

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Teva Branded Pharmaceutical Products R&D, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Teva Pharma GmbH
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	Graf-Arco-Str.3
B.5.3.2	Town/ city	Ulm
B.5.3.3	Post code	89079
B.5.3.4	Country	Germany
B.5.4	Telephone number	900 811 335
B.5.6	E-mail	Info.era-clinical@teva.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TEV-48125
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fremanezumab
D.3.9.1	CAS number	1655501-53-3
D.3.9.2	Current sponsor code	TEV 48125
D.3.9.3	Other descriptive name	TEV 48125
D.3.9.4	EV Substance Code	SUB181665
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Episodic and Chronic Migraine

Migraña episódica y crónica

E.1.1.1

Medical condition in easily understood language

Episodic and Chronic Migraine

Migraña episódica y crónica

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10066636
E.1.2	Term	Chronic migraine
E.1.2	System Organ Class	100000004852

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10027602
E.1.2	Term	Migraine headache
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study is to evaluate the long-term safety and tolerability of sc TEV 48125 in the preventive treatment of migraine.

El objetivo principal de este estudio es evaluar la seguridad y tolerabilidad a largo plazo de TEV-48125 subcutáneo (s.c.) en el tratamiento preventivo de la migraña.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients Rolling Over from the Pivotal Efficacy Studies: Patients may be included in this study only if they meet all of the following criteria:
a. Patient signs and dates the informed consent document.
b. Patient must have completed the pivotal efficacy study without major protocol violations.
c. Patients may continue with a stable dose/regimen of the preventive medication they were taking during the pivotal efficacy studies.
d. Patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.

Patients Not Rolling Over from the Pivotal Efficacy Studies: Patients may be included in this study only if they meet all of the following criteria:
a. Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age.
b. Patient signs and dates the informed consent document.
c. Patient has history of migraine (according to ICHD-3 criteria [Classification Committee of the IHS, 2013]) or clinical judgment suggests a migraine diagnosis (not better accounted for by another ICHD-3 diagnosis) for ≥12 months prior to screening.
d. Patient fulfills the following criteria for EM or CM with prospectively collected baseline information during the 28-day run-in period:
-Patients with EM:
○ headache occurring on ≥4 and ≤14 days
○ on ≥4 days, fulfilling any of the following:
 ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura
 ICHD-3 criteria B and C for 1.2 Migraine with aura
 Probable migraine (a migraine subtype where only 1 migraine criterion is missing)
 The patient used a triptan or ergot derivative to treat an established headache.
- Patients with CM:
○ headache occurring on ≥15 days
○ on ≥8 days, fulfilling any of the following:
 ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura
 ICHD-3 criteria B and C for 1.2 Migraine with aura
 Probable migraine (a migraine subtype where only 1 migraine criterion is missing)
 The patient used a triptan or ergot derivative to treat an established headache.
e. Not using preventive medications (ie, at least 5 half-lives have passed since last use) or using no more than 1 preventive medication for migraine or other medical conditions (eg, propranolol used for hypertension) if the dose and regimen have been stable for at least 2 months prior to beginning the 28-day run-in period.
f. Body mass index of 17.5 to 37.5 kg/m2 and a total body weight between 45 and 120 kg, inclusive
g. All patients must be of nonchildbearing potential, defined as:
- women surgically sterile by documented complete hysterectomy, bilateral oophorectomy, or bitubal ligations or confirmed to be postmenopausal (at least 1 year since last menses and follicle-stimulating hormone above 35 U/L)
- men surgically sterile by documented vasectomy
or
if of childbearing potential, patients must meet any of the following criteria:
- Patients must simultaneously use 2 forms of highly effective contraception methods with their partners during the entire study period and for 7.5 months after the last dose of study drug.
- Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods),
declaration of abstinence for the duration of a study, and withdrawal are not acceptable methods of contraception.
h. Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).
i. The patient demonstrated compliance with the electronic headache diary during the run-in period by entry of headache data on a minimum of 24 out of 28 days (~85% diary compliance).
j. The patient is in good health as determined by a medical and psychiatric history, medical examination, 12-lead ECG, serum chemistry, hematology, coagulation, and urinalysis.
k. The patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.

Patients Rolling Over from the Pivotal Efficacy Studies for ADA Assessment Only: Patients may be included in this study if they sign and date the informed consent document.

Pacientes procedentes de los estudios de eficacia pivotales: Los pacientes solo podrán ser incluidos en este estudio si cumplen todos los criterios siguientes:
a. Que el paciente firme y feche el documento de consentimiento informado.
b. Que el paciente haya completado el estudio de eficacia pivotal sin infracciones importantes del protocolo.
c. Los pacientes deben continuar con una dosis/pauta estable de la medicación preventiva que estuvieran tomando durante los estudios de eficacia pivotales.
d. Los pacientes deben estar dispuestos y ser capaces de cumplir con las limitaciones del estudio, permanecer en la consulta el tiempo exigido durante el periodo del estudio y volver a la consulta para la evaluación del seguimiento, como se especifica en este protocolo.
Pacientes no procedentes de los estudios de eficacia pivotales: Los pacientes solo podrán ser incluidos en este estudio si cumplen todos los criterios siguientes:
a. Pacientes de ambos sexos de entre 18 y 70 años de edad, ambos inclusive, con aparición de la migraña ≤50 años.
b. Que el paciente firme y feche el documento de consentimiento informado.
c. Paciente con antecedentes de migraña (según los criterios de la ICHD-3 [IHS 2013]) o con criterio clínico que indica diagnóstico de migraña (no explicado mejor por otro diagnóstico de la ICHD-3) durante ≥12 meses antes de la selección.
d. Paciente que cumple los siguientes criterios de ME o MC con información inicial recopilada de forma prospectiva durante el periodo de preinclusión de 28 días:
− Pacientes con ME:
-cefalea que se produce ≥4 y ≤14 días
-se produce ≥4 días, cumpliendo los requisitos del protocolo
− Pacientes con MC:
-cefalea que se produce durante ≥15 días
-se produce ≥8 días, cumpliendo los requisitos del protocolo
e. No utilización de medicación preventiva (expuesta en el Anexo B) (es decir, que hayan transcurrido al menos 5 semividas desde el último uso) o utilización de un máximo de 1 medicación preventiva (expuesta en el Anexo A) para la migraña o para otras afecciones médicas (p. ej., uso de propranolol para la hipertensión) si la dosis y la pauta se han mantenido estables durante al menos 2 meses antes del comienzo del periodo de preinclusión de 28 días.
f. Índice de masa corporal de 17,5 a 37,5 kg/m2 y un peso corporal total de entre 45 y 120 kg, ambos inclusive.
g. Es preciso que ningún paciente pueda considerarse fértil, lo que se define como:
− mujeres con esterilización quirúrgica mediante histerectomía completa, ovariectomía bilateral o ligadura de trompas bilateral documentadas, o con menopausia confirmada (al menos 1 año desde la última menstruación y concentración de hormona foliculoestimulante por encima de 35 U/l)
− varones con esterilización quirúrgica mediante vasectomía documentada
o
si están en edad fértil, los pacientes deben cumplir alguno de los siguientes criterios:
− Los pacientes deben utilizar simultáneamente 2 formas de métodos anticonceptivos de alta eficacia (definidos en la Sección 5.2) con sus parejas durante todo el periodo del estudio y durante 7 meses y medio después de la última dosis del fármaco del estudio.
− La abstinencia sexual solo se considerará un método altamente efectivo si se define como no mantener relaciones heterosexuales dentro del periodo definido. La fiabilidad de la abstinencia sexual debe evaluarse en relación con la duración del estudio clínico y el estilo de vida preferido y habitual del sujeto. La abstinencia periódica (p. ej., los métodos del calendario, de la ovulación, sintotérmico o posovulatorio), la declaración de abstinencia para toda la duración de un estudio y el coito interrumpido no se consideran métodos anticonceptivos aceptables.
h. Las pacientes en edad fértil deben presentar una prueba de embarazo con hormona gonadotropina coriónica humana beta (β-HCG) negativa en la selección (confirmada mediante prueba de embarazo β-HCG en orina en el momento inicial).
i. El paciente demostró cumplimiento con el diario electrónico de cefaleas durante el periodo de preinclusión introduciendo datos sobre las cefaleas en un mínimo de 24 de los 28 días (cumplimiento del diario ~85%).
j. El paciente goza de buena salud según sus antecedentes médicos y psiquiátricos, la exploración física, el ECG de 12 derivaciones, la bioquímica sérica, la hematología, la coagulación y el análisis de orina.
k. El paciente debe estar dispuesto y ser capaz de cumplir con las limitaciones del estudio, permanecer en la consulta el tiempo exigido durante el periodo del estudio y volver a la consulta para la evaluación del seguimiento, como se especifica en este protocolo.
Pacientes procedentes de los estudios de eficacia pivotales solo para evaluación de los AAF: Los pacientes pueden ser incluidos en este estudio si firman y fechan el documento de consentimiento informado.

E.4

Principal exclusion criteria

Patients Rolling Over from the Pivotal Efficacy Studies: Patients will be excluded from participating in this study if they meet any of the following criteria:
a. Any finding that, in the judgment of the investigator, is clinically significantly abnormal, including hematology values, serum chemistry, coagulation tests, or urinalysis (abnormal tests may be repeated for confirmation)
b. Pregnant or nursing females
c. Any finding in the baseline 12-lead ECG considered clinically significant in the judgment of the investigator
d. Compliance with daily diary entry lower than 75% at the last month of the double-blind treatment period of the pivotal efficacy study

Patients Not Rolling Over from the Pivotal Efficacy Studies: Patients will be excluded from participating in this study if they meet any of the following criteria:
a. Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator
b. Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years
c. History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events) such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
d. Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
e. Past or current history of cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma
f. Pregnant or nursing females
g. History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
h. Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study drug administration or 5 half-lives, whichever is longer
I. Any finding in the baseline 12 lead ECG considered clinically significant in the judgment of the investigator
j. Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation)
k. Hepatic enzymes (alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase) >1.5 × the upper limit of the normal range (ULN) after confirmation in a repeat test or suspected hepatocellular damage that fulfills criteria for Hy’s law at screening
l. Serum creatinine >1.5 × the ULN, clinically significant proteinuria, or evidence of renal disease at screening
m. History of alcohol or drug abuse during the past 2 years, or alcohol or drug dependence during the past 5 years
n. The patient cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons:
- mentally or legally incapacitated or unable to give consent for any reason
- in custody due to an administrative or a legal decision, under guardianship, or institutionalized
- unable to be contacted in case of emergency
- has any other condition, which, in the opinion of the investigator, makes the patient inappropriate for inclusion in the study
o. Patient is a study center or sponsor employee who is directly involved in the study or the relative of such an employee.

Patients Rolling Over from the Pivotal Efficacy Studies for ADA Assessment Only: Not applicable.

Pacientes procedentes de los estudios de eficacia pivotales: Los pacientes serán excluidos de la participación en este estudio si cumplen cualquiera de los siguientes criterios:
a. Cualquier hallazgo anómalo que, según el criterio del investigador, sea clínicamente significativo, incluidos valores de hematología, bioquímica sérica, pruebas de coagulación o análisis de orina (los resultados anómalos de las pruebas se pueden repetir para su confirmación)
b. Mujeres embarazadas o que estén en periodo de lactancia
c. Cualquier hallazgo en el ECG de 12 derivaciones basal considerado clínicamente significativo a criterio del investigador
d. Cumplimiento de las anotaciones diarias en el diario inferior al 75% en el último mes del periodo de tratamiento con doble enmascaramiento del estudio de eficacia pivotal
Pacientes no procedentes de los estudios de eficacia pivotales: Los pacientes serán excluidos de la participación en este estudio si cumplen cualquiera de los siguientes criterios:
a. Enfermedad hematológica, cardíaca, renal, endocrina, pulmonar, gastrointestinal, genitourinaria, neurológica, hepática u ocular clínicamente significativa, a criterio del investigador
b. Indicios o historial médico de problemas psiquiátricos clínicamente significativos, como cualquier intento de suicidio en el pasado, o ideas suicidas con un plan específico en los 2 años anteriores
c. Antecedentes de enfermedad cardiovascular o isquemia vascular (ya sea miocárdica, neurológica [p. ej., isquemia cerebral], isquemia de las extremidades periféricas u otro episodio isquémico) o acontecimientos tromboembólicos (acontecimientos trombóticos o embólicos arteriales o venosos), como accidentes cerebrovasculares (incluidos los accidentes isquémicos transitorios), trombosis venosa profunda o embolia pulmonar, clínicamente significativos
d. Infección conocida o antecedentes de infección por el virus de la inmunodeficiencia humana, tuberculosis o hepatitis B o C
e. Antecedentes antiguos o actuales de cáncer en los últimos 5 años, excepto carcinoma cutáneo distinto a melanoma tratado adecuadamente
f. Mujeres embarazadas o que estén en periodo de lactancia
g. Antecedentes de reacciones de hipersensibilidad a proteínas inyectadas, incluidos anticuerpos monoclonales
h. Participación en un estudio clínico de un nuevo producto químico o de un medicamento de venta con receta en los 2 meses anteriores a la administración del fármaco del estudio o 5 semividas, lo que sea más largo
i. Cualquier hallazgo en el ECG de 12 derivaciones basal considerado clínicamente significativo a criterio del investigador
j. Cualquier hallazgo anómalo que, según el criterio del investigador, sea clínicamente significativo, incluidos valores de bioquímica sérica, hematología, pruebas de coagulación o análisis de orina (los resultados anómalos de las pruebas se pueden repetir para su confirmación)
k. Enzimas hepáticas (alanina aminotransferasa, aspartato aminotransferasa y fosfatasa alcalina)>1,5 x el límite superior de la normalidad (LSN) tras su confirmación en un análisis repetido o sospecha de lesión hepatocelular que cumpla los criterios de la ley de Hy en la selección
l. Creatinina sérica>1,5 x el LSN, proteinuria clínicamente significativa o indicios de enfermedad renal en la selección
m. Antecedentes de consumo excesivo de alcohol o drogas durante los 2 últimos años, o dependencia del alcohol o de las drogas durante los 5 últimos años
n. El paciente no puede participar o completar el estudio de forma satisfactoria, en opinión de su proveedor de asistencia sanitaria o del investigador, por alguna de las siguientes razones:
− incapacidad metal o legal o incapaz de dar su consentimiento por cualquier razón
− en custodia por una decisión administrativa o legal, en tutelaje o ingresado en una institución
− imposibilidad de contactar con él en caso de emergencia
− tiene otra enfermedad que, en opinión del investigador, hace que el paciente no sea adecuado para su inclusión en el estudio
o. El paciente es un trabajador del centro del estudio o del promotor que está directamente implicado en el estudio o es un familiar de ese tipo de empleado.
Pacientes procedentes de los estudios de eficacia pivotales solo para evaluación de los AAF: No corresponde.

E.5 End points

E.5.1

Primary end point(s)

• occurrence of adverse events throughout the study
• changes from baseline in clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis) test results
• abnormal standard 12-lead electrocardiogram (ECG) findings
• changes from baseline in vital signs (pulse, systolic and diastolic blood pressure, body temperature, and respiratory rate) measurements
• abnormal physical examination findings
• abnormal local injection site tolerability findings (ie, erythema, induration, and ecchymosis) and occurrence of injection site pain
• suicidal ideation and behavior as suggested by the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)

•acontecimientos adversos producidos durante el estudio
•cambios respecto a los valores iniciales de los resultados de las pruebas analíticas (bioquímica sérica, hematología, coagulación y análisis de orina)
•anomalías en el electrocardiograma (ECG) estándar de 12 derivaciones
•cambios respecto a los valores iniciales de las determinaciones de las constantes vitales (pulso, presión arterial sistólica y diastólica, temperatura corporal y frecuencia respiratoria)
•hallazgos anómalos de la exploración física
•hallazgos anómalos de tolerabilidad en la zona de inyección (como eritema, induración y equimosis) y dolor en la zona de inyección
•ideas y comportamiento suicidas según la Escala electrónica Columbia para evaluar la gravedad de las conductas suicidas (electronic Columbia-Suicide Severity Rating Scale, eC-SSRS)

E.5.1.1

Timepoint(s) of evaluation of this end point

Throughout the study

A lo largo del estudio

E.5.2

Secondary end point(s)

There are no secondary efficacy endpoints

No hay criterios de valoración secundarios

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

No aplicable

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Czech Republic

Germany

Israel

Japan

Poland

Russian Federation

Spain

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of the study is defined as the date the last patient attends the follow-up visit

En fin de estudio se define como la fecha del último paciente que acude a la visita de seguimiento.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

1692

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-06-09.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

271

F.4.2.2

In the whole clinical trial

1842

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No further treatment and medical supervision of the patients after the end of the clinical trial is planned for the above clinical trial. Those patients who complete the study will receive standard of care from their doctors.

No se prevee tratamiento o supervisión médica adicional tras la finalización del ensayo. Los pacientes recibiran el tratamiento habitual de sus médicos.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-08-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-07-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-12-07

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